Trial Outcomes & Findings for A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects (NCT NCT01842607)

NCT ID: NCT01842607

Last Updated: 2018-08-06

Results Overview

AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 651 participants
• Primary outcome timeframe: From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose])
• Results posted on: 2018-08-06

Participant Flow

This study was an extension of MEA115588 (NCT01691521) and MEA115575 (NCT01691508). Participants who completed the prior studies were offered to enroll in this study. Assessments that were captured as part of exit visit for MEA115588 and MEA115575 served as Baseline visit for this study.

651 participants who completed the study MEA115588 or MEA115575 were enrolled in this study. Participants meeting all the inclusion criteria and none of the exclusion criteria received their first mepolizumab dose at Visit 1 and continued to receive mepolizumab subcutaneous (SC) injections approximately every 4 weeks for 12 months.

Participant milestones

Measure	Mepolizumab 100 mg SC Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Overall Study STARTED	651
Overall Study COMPLETED	585
Overall Study NOT COMPLETED	66

Reasons for withdrawal

Measure	Mepolizumab 100 mg SC Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Overall Study Adverse Event	11
Overall Study Lack of Efficacy	19
Overall Study Protocol Violation	8
Overall Study Protocol defined stopping criteria	2
Overall Study Lost to Follow-up	3
Overall Study Physician Decision	9
Overall Study Withdrawal by Subject	14

Baseline Characteristics

A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects

Baseline characteristics by cohort

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Age, Continuous	51.1 Years STANDARD_DEVIATION 13.87 • n=5 Participants
Sex: Female, Male Female	360 Participants n=5 Participants
Sex: Female, Male Male	291 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	14 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	44 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	45 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	7 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	13 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	517 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose])

Population: As Treated (AT) Population: all participants who received at least one dose of open label mepolizumab.

AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions Any AEs	558 Participants
Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions AEs related to study treatment	119 Participants
Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions Any SAEs	94 Participants
Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions SAEs related to study treatment	1 Participants
Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions Fatal SAEs	0 Participants

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population. Only those participants available at the indicated timepoints were analyzed (represented by n=X in the category titles).

Blood samples were collected for the determination of anti-mepolizumab antibodies (ADA) just prior to administration of mepolizumab at indicated time points. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. Participants who switched from the 250 mg vial to the 100 mg vial required one immunogenicity sample prior to the first dose from the 100 mg vial and one sample prior to the second dose from the 100 mg vial at the next visit. The highest value post-baseline visit are based on each participant's highest post-baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-baseline would be positive for a participant who had both negative and positive post-baseline results.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points Highest value post-baseline, ADA, positive, n=646	31 Participants
Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points Highest value post-baseline, ADA, negative, n=646	615 Participants
Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points Highest value post-baseline, NAb, positive, n=31	0 Participants
Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points Highest value post-baseline, NAb, negative, n=31	31 Participants

SECONDARY outcome

Timeframe: Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose

Population: AT Population

Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of region, exacerbations in the year prior to the start of MEA115588 or MEA115575 (as an ordinal variable) and baseline percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Annualized Rate of Exacerbations Per Year	0.93 Exacerbations per year Interval 0.83 to 1.04

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 4, n=603	-0.09 Score on scale Standard Deviation 0.812
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 16, n=592	-0.11 Score on scale Standard Deviation 0.920
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 28, n=577	-0.05 Score on scale Standard Deviation 1.021
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 40, n=564	-0.10 Score on scale Standard Deviation 0.944
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 52, n=556	-0.09 Score on scale Standard Deviation 0.990
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Follow-up visit, n=338	0.20 Score on scale Standard Deviation 1.132

SECONDARY outcome

Timeframe: From Baseline and up to Week 52

Population: AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 28 and Week 52. Spirometry was performed within ± 1 hour of the Baseline assessment. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 16, n=632	67 Milliliters (mL) Standard Deviation 362.7
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 28, n=615	50 Milliliters (mL) Standard Deviation 409.8
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 52, n=602	29 Milliliters (mL) Standard Deviation 406.2

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population.

AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study Withdrawals due to lack of efficacy	19 Participants
Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study Withdrawals due to adverse events	11 Participants

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population

AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants Hospitalized Due to Exacerbations and Adverse Events No hospitalisation due to exacerbations	612 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events One time hospitalisation due to exacerbations	29 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Two times hospitalisation due to exacerbations	4 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Three times hospitalisation due to exacerbations	4 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Four times hospitalisation due to exacerbations	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Five times hospitalisation due to exacerbations	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Six times hospitalisation due to exacerbations	1 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Seven times hospitalisation due to exacerbations	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Eight times hospitalisation due to exacerbations	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Nine times hospitalisation due to exacerbations	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Ten times hospitalisation due to exacerbations	1 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events No hospitalisation due to AEs	560 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events One time hospitalisation due to AEs	61 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Two times hospitalisation due to AEs	13 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Three times hospitalisation due to AEs	11 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Four times hospitalisation due to AEs	4 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Five times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Six times hospitalisation due to AEs	1 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Seven times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Eight times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Nine times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Ten times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Eleven times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Twelve times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Thirteen times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Fourteen times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Fifteen times hospitalisation due to AEs	0 Participants
Number of Participants Hospitalized Due to Exacerbations and Adverse Events Sixteen times hospitalisation due to AEs	1 Participants

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population

Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Hypersensitivity reactions (i.e., allergic or IgE-mediated reactions) were monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint NIAID/FAAN Second Symposium on Anaphylaxis. Information was also collected to assess localized site reactions as determined by the investigator. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions Any systemic infusion/injection site reaction	13 Participants
Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions Injection related reaction	7 Participants
Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions Hypersensitvity	4 Participants
Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions Type IV hypersensitivity reaction	3 Participants
Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions Any local infusion/injection site reaction	29 Participants

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population, only participants with ECG results post-baseline were analyzed

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). ECG findings were summarised at any time post Baseline for participants as normal, abnormal-not clinically significant(A-NCS) and abnormal-clinically significant (A-CS).

Outcome measures

Measure	Mepolizumab 100 mg SC n=638 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline Normal	262 Participants
Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline A-NCS	295 Participants
Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline A-CS	81 Participants

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose) QTcF, Week 52, n=573	-3.5 Milliseconds (msec) Standard Deviation 15.68
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose) QTcB, Week 28, n=592	-5.5 Milliseconds (msec) Standard Deviation 19.10
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose) QTcB, Week 52, n=573	-3.2 Milliseconds (msec) Standard Deviation 18.90
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose) QTcB, Follow-up, n=299	-3.4 Milliseconds (msec) Standard Deviation 19.67
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose) QTcF, Week 28, n=592	-7.1 Milliseconds (msec) Standard Deviation 16.15
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose) QTcF, Follow-up, n=299	-5.5 Milliseconds (msec) Standard Deviation 17.01

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.

Outcome measures

Measure	Mepolizumab 100 mg SC n=614 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline MC <-60, n=614	2 Participants
Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline MC >=-60 to <-30, n=614	11 Participants
Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline MC >=-30 to <0, n=614	252 Participants
Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline MC >=0 to <30, n=614	328 Participants
Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline MC >=30 to <60, n=614	20 Participants
Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline MC >=60, n=614	1 Participants

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Measure	Mepolizumab 100 mg SC n=614 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline MC <-60, n=614	3 participants
Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline MC >=-60 to <-30, n=614	16 participants
Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline MC >=-30 to <0, n=614	222 participants
Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline MC >=0 to <30, n=614	330 participants
Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline MC >=30 to <60, n=614	41 participants
Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline MC >=60, n=614	2 participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.

Outcome measures

Measure	Mepolizumab 100 mg SC n=581 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52 SBP, Week 52, n=581	0.3 Millimeter of mercury (mmHg) Standard Deviation 12.90
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52 DBP, Week 52, n=581	-0.4 Millimeter of mercury (mmHg) Standard Deviation 9.47

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Vital sign measurements including sitting pulse was performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Change From Baseline in Pulse Rate Assessed at Week 52	0.2 Beats per minute (BPM) Standard Deviation 10.52

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).

Clinical chemistry laboratory parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, high density lipoprotein (HDL) cholesterol, indirect bilirubin, low density lipoprotein (LDL) cholesterol, lactate dehydrogenase, phosphate, plasma/serum protein, potassium, serum glucose, sodium, triglycerides, urea, and very low density lipoprotein (VLDL) cholesterol assessed at the indicated time points. Laboratory abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline VLDL cholesterol, Low, n=605	13 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline VLDL cholesterol, High, n=605	99 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Alanine aminotransferase, High, n=649	70 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Albumin, Low, n=649	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Albumin, High, n=649	23 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Alkaline phosphatase, High, n=649	37 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Aspartate aminotransferase, High, n=649	53 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Bilirubin, High, n=649	38 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Calcium, Low, n=649	19 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Calcium, High, n=649	49 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Chloride, Low, n=649	9 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Chloride, High, n=649	126 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Cholesterol, High, n=649	492 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Creatine kinase, High, n=649	178 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Creatinine, Low, n=649	170 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Creatinine, High, n=649	18 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Direct bilirubin, High, n=649	10 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Gamma glutamyl transferase, High, n=649	146 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline HDL cholesterol, Low, n=616	22 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Indirect bilirubin, High, n=649	12 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline LDL cholesterol, High, n=604	207 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Lactate dehydrogenase, High, n=649	36 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Phosphate, Low, n=649	149 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Phosphate, High, n=649	84 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Plasma/serum protein, Low, n=649	29 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Potassium, Low, n=649	24 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Potassium, High, n=649	22 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Serum glucose, Low, n=649	62 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Serum glucose, High, n=649	239 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Sodium, Low, n=649	25 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Sodium, High, n=649	9 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Triglycerides, High, n=617	102 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Urea, Low, n=649	17 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline Urea, High, n=649	53 Participants

SECONDARY outcome

Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Population: AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).

Haematology laboratory parameters included basophils, basophils/leukocytes, blood erythrocytes, blood leukocytes, eosinophils, eosinophils/leukocytes, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes distribution width (EDW), hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils segmented (NS), neutrophils/leukocytes, platelets, reticulocytes assessed at Baseline, Week 4, Week 16, Week 28, Week 52 and follow-up visit (approx. 12 weeks post-last dose). Hematology abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline is equal to all visits (including scheduled and unscheduled) post Baseline were considered for this visit derivation. If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.

Outcome measures

Measure	Mepolizumab 100 mg SC n=651 Participants Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline MCH, Low, n=649	58 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Basophils, High, n=649	2 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Basophils/Leukocytes, High, n=649	3 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Blood Erythrocytes, Low, n=649	52 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Blood Erythrocytes, High, n=649	36 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Blood Leukocytes, Low, n=649	25 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Blood Leukocytes, High, n=649	146 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Eosinophils, Low, n=649	429 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Eosinophils, High, n=649	51 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Eosinophils/Leukocytes, High, n=649	60 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline MCHC, Low, n=649	276 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline MCH, High, n=649	26 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline MCV, Low, n=649	32 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline MCV, High, n=649	32 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline EDW, High, n=649	322 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Hematocrit, Low, n=649	57 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Hematocrit, High, n=649	94 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Hemoglobin, Low, n=649	116 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Hemoglobin, High, n=649	14 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Lymphocytes, Low, n=649	48 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Lymphocytes, High, n=649	25 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Lymphocytes/Leukocytes, Low, n=649	168 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Lymphocytes/Leukocytes, High, n=649	68 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Monocytes, Low, n=649	156 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Monocytes, High, n=649	15 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Monocytes/Leukocytes, High, n=649	45 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline NS, Low, n=649	31 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline NS, High, n=649	151 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Neutrophils/Leukocytes, Low, n=649	39 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Neutrophils/Leukocytes, High, n=649	226 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Platelets, Low, n=649	8 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Platelets, High, n=649	58 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Reticulocytes, Low, n=649	77 Participants
Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline Reticulocytes, High, n=649	294 Participants

Adverse Events

Mepolizumab 100 mg SC

Serious events: 94 serious events

Other events: 461 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mepolizumab 100 mg SC n=651 participants at risk Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Respiratory, thoracic and mediastinal disorders Asthma	5.8% 38/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Pneumonia	0.61% 4/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Appendicitis	0.31% 2/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Bronchitis	0.31% 2/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Diverticulitis	0.31% 2/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Upper respiratory tract infection	0.31% 2/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Aspergillus infection	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Cellulitis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Chronic sinusitis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Enteritis infectious	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Gastroenteritis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations H1N1 influenza	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Influenza	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Labyrinthitis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Pharyngeal abscess	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Pyelonephritis acute	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Respiratory tract infection	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Sinusitis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Staphylococcal bacteraemia	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Urinary tract infection	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Wound infection staphylococcal	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Abdominal pain upper	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Diarrhoea	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Dyskinesia oesophageal	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Dyspepsia	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Haemorrhoids	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Ileus paralytic	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Inguinal hernia	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Acetabulum fracture	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Brain contusion	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Fibula fracture	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Laceration	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Radius fracture	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Rib fracture	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Skull fracture	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Spinal compression fracture	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Thermal burn	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Injury, poisoning and procedural complications Tibia fracture	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Cardiac disorders Atrial fibrillation	0.46% 3/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Cardiac disorders Angina pectoris	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Cardiac disorders Cardio-respiratory arrest	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Cardiac disorders Hypertensive heart disease	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Cardiac disorders Mitral valve incompetence	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Cardiac disorders Myocardial infarction	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Nervous system disorders Cerebral haemorrhage	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Nervous system disorders Headache	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Nervous system disorders Restless legs syndrome	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Nervous system disorders VIIth nerve paralysis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Hepatobiliary disorders Cholelithiasis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Hepatobiliary disorders Gallbladder disorder	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Hepatobiliary disorders Jaundice cholestatic	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Immune system disorders Anaphylactic reaction	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Immune system disorders Anaphylactic shock	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Immune system disorders Type IV hypersensitivity reaction	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Psychiatric disorders Depression	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Psychiatric disorders Panic attack	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Renal and urinary disorders Nephrocalcinosis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Renal and urinary disorders Urinary tract pain	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Vascular disorders Deep vein thrombosis	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Vascular disorders Hypotension	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Ear and labyrinth disorders Vertigo	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Eye disorders Retinal detachment	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
General disorders Non-cardiac chest pain	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Investigations Ejection fraction decreased	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Reproductive system and breast disorders Ovarian cyst	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Skin and subcutaneous tissue disorders Angioedema	0.15% 1/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.

Other adverse events

Measure	Mepolizumab 100 mg SC n=651 participants at risk Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
Infections and infestations Nasopharyngitis	30.1% 196/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Upper respiratory tract infection	15.2% 99/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Bronchitis	12.0% 78/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Sinusitis	10.1% 66/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Influenza	4.3% 28/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Lower respiratory tract infection	4.0% 26/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Rhinitis	3.5% 23/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Infections and infestations Urinary tract infection	3.2% 21/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Musculoskeletal and connective tissue disorders Back pain	7.1% 46/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Musculoskeletal and connective tissue disorders Arthralgia	6.8% 44/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.2% 21/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 21/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Asthma	9.4% 61/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.2% 34/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Respiratory, thoracic and mediastinal disorders Cough	4.0% 26/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Nervous system disorders Headache	13.4% 87/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
General disorders Injection site reaction	4.5% 29/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
General disorders Fatigue	3.7% 24/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Nausea	4.1% 27/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
Gastrointestinal disorders Diarrhoea	3.2% 21/651 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks. Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER